Abstract

Claims

A pharmaceutical formulation for intranasal delivery of diazepam, comprising an aqueous suspension of diazepam at a concentration of at least about 25 mg/ml, a suspending agent, and a surfactant.

The pharmaceutical formulation of claim 1, wherein the suspending agent is one or more molecules selected from the group consisting of methylcellulose; hydroxypropylniethylcellulose; hydroxypropylmethylcellulose acetate succinate, carboxymethylcellulose, HPMC 2910, HPMC 2208, and polyvinyl alcohol.

The pharmaceutical formulation of claim 1, wherein the surfactant is selected from the group consisting of polysorbate 80, polysorbate 20 and polyethylene glycol 400 monolaurate.

The pharmaceutical formulation of any of claims 1-4, further comprising a cosolvent.

The pharmaceutical formulation of claim 5, wherein the cosolvent is one or more molecules selected from the group consisting of ethanol, polyethylene glycol, and polyethylene glycol 400 (PEG 400).

The pharmaceutical formulation of any of claims claim 1-6, wherein the concentration of diazepam is at least about 40 mg/ml.

The pharmaceutical formulation of any of claims claim 1-6, wherein the concentration of diazepam is at least about 50 mg/ml.

The pharmaceutical formulation of any of claims 1-8, further comprising a preservative.

The pharmaceutical formulation of claim9, wherein the preservative is selected from the group consisting of benzalkonium chloride, chlorobutanol, methylparaben, propylparaben, ethylparpaben, phenol, and m-cresol.

The pharmaceutical formulation of any of claims 1-10, wherein the formulation is produced by mixing with glass beads.

The pharmaceutical formulation of any of claims 1-10, wherein the formulation is produced by homogenization.

The pharmaceutical formulation of any of claims 1-10, comprising particles having diameters from about 1 nanometer to about 1000 nanometers.

The pharmaceutical formulation of claim 13, wherein at least about 80 percent of particles are less than about 30 nanometers in size.

The pharmaceutical formulation of claim 14, wherein the particle size distribution is mono-disperse.

The pharmaceutical formulation of any of claims 1-15, further comprising a dispersion agent.

A pharmaceutical formulation for intranasal delivery of diazepam, comprising a non-aqueous solution of diazepam at a concentration of at least about 25 mg/ml, one or more suspending agents, one or more mucosal delivery enhancing agents.

A pharmaceutical formulation for intranasal delivery of diazepam, comprising an aqueous solution of diazepam at a concentration of at least about 25 mg/ml, a cosolvent and a surfactant.

The pharmaceutical formulation of claim 19, wherein the surfactant is selected from the group consisting of polysorbate 80, polysorbate 20, caprylocaproyl macrogolglyceride, and polyethylene glycol 400 monolaurate.

The pharmaceutical formulation of claim 19, wherein the cosolvent is one or more molecules selected from the group consisting of ethanol, polyethylene glycol, and polyethylene glycol 400 (PEG 400).

A method for delivering diazepam intranasally, comprising preparing a pharmaceutical formulation of any of claims 1-21, and intranasally administering the pharmaceutical formulation to a patient in need thereof.